Status:
TERMINATED
Zevalin Twice in Aggressive Non-Hodgkin Lymphoma
Lead Sponsor:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the c...
Detailed Description
The objectives of this study are to evaluate the efficacy and safety of two sequential doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory ag...
Eligibility Criteria
Inclusion
- Age 18-75
- Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
- Stage II, III, IV according to Ann Arbor criteria
- Chemoresistant disease after first line treatment (CHOP-like + Rituximab) or relapsed patients after one or two lines of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation
- Performance status 0-2 according to WHO criteria
- HIV negativity
- Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min
- Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 150 x 109/l and bone marrow involvement \< 25% before first Zevalin infusion.
- Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
- Use of effective contraception for the entire treatment period in patients sexually active
- Negative pregnancy test in child bearing potential women
- Life expectancy \> 6 months
- Written informed consent
Exclusion
- More than two lines of prior chemotherapy before study entry
- Prior high dose chemotherapy and autologous stem cell transplantation
- HIV positivity
- HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- Pregnant or breastfeeding
- CNS lymphoma involvement.
- History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
- Cardiac failure with VEF \< 40%
- Clinical evidence of not controlled infections
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00902525
Start Date
January 1 2008
End Date
September 1 2011
Last Update
December 31 2012
Active Locations (12)
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1
Divisione di Ematologia Ospedale SS Antonio e Biagio
Alessandria, AL, Italy, 15100
2
Istituto di Ematologia e Oncologia Medica L. Seragnoli Policlinco S. Orsola
Bologna, BO, Italy, 40138
3
Divisione di Ematologia, Spedali Civili
Brescia, BS, Italy, 25100
4
Divisione di Ematologia Ospedale Centrale di Bolzano
Bolzano, BZ, Italy, 39100